Flourish Vaginal Care system for Neovaginal Microbiome

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Papillon Wellness Center, New Hope, PA
Neovaginal Microbiome
Flourish Vaginal Care system - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial looks at whether a vaginal wellness system can help establish a microbiome in transgender women. The Flourish Vaginal Care system is being used in a trial to treat Neovaginal Microbiome, and there is no placebo group. The system has previously been approved by the FDA for a different condition.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 1 Secondary · Reporting Duration: Collections at time 0, 6 weeks, and 6 months

Month 6
VSQ
Vaginal microbiome
Vaginal pH

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Group 2: Transgender women not using Flourish
1 of 2
Group 1: Transgender women using Flourish
1 of 2
Active Control
Experimental Treatment

60 Total Participants · 2 Treatment Groups

Primary Treatment: Flourish Vaginal Care system · No Placebo Group · N/A

Group 1: Transgender women using Flourish
Device
Experimental Group · 1 Intervention: Flourish Vaginal Care system · Intervention Types: Device
Group 2: Transgender women not using FlourishNoIntervention Group · 1 Intervention: Group 2: Transgender women not using Flourish · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: collections at time 0, 6 weeks, and 6 months
Closest Location: Papillon Wellness Center · New Hope, PA
Photo of pennsylvania 1Photo of pennsylvania 2Photo of pennsylvania 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Neovaginal Microbiome
0 CompletedClinical Trials

Who is running the clinical trial?

Sexual Health and Wellness InstituteLead Sponsor
5 Previous Clinical Trials
158 Total Patients Enrolled
Papillon CenterUNKNOWN
Christine McGinn, DOPrincipal InvestigatorPapillon Center

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.